Search Results

Symbotex™ Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.
ProGrip™ Self-Gripping Polyester Mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair.
Parietex™ Hydrophilic 2D 3D Anatomical Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving inguinal and incisional hernia repairs.
Versatex™ Monofilament Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repairs.

The purpose of this Special 510(k) is to notify the Agency the changes made on Instructions for Use. There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices Symbotex™ Composite Mesh (K142908), ProGrip™ Self-Gripping Polyester Mesh (K142900), Parietex™ Hydrophilic 2D 3D Anatomical Mesh (K173796) and Versatex™ Monofilament Mesh (K150091).
Symbotex™ Composite Mesh is made out of a three-dimensional monofilament polyester textile which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Nonabsorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polvester textile flap is attached to the threedimensional reinforcement and helps place and fix the mesh.
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, positioning and fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps orientation.
The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.
Two or three-dimensional multifilament polyester wall reinforcements.
The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The textures and transparencies of this mesh make them particularly suitable for the treatment of parietal affections, in particular inguinal hernias, through laparoscopic approach.
The three-dimensional mesh (TET references) has hexagonal pores. The flexibility, porosity and low density of this mesh make it particularly suitable for the treatment of parietal affections, in particular incisional and inquinal hernias, through open approach.
The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a pre-peritoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord.
The anatomical mesh is mainly designed for the repair of inquinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.
Versatex™ Monofilament Mesh is made of macroporous three-dimensional monofilament polyester textile. Largest sizes include a green dyed monofilament polyester (D&C Green No. 6) marking that is positioned in the center of the textile to help center and orient the mesh.

This document is a 510(k) summary for several surgical mesh products submitted to the FDA. The submission is not for a new device but rather to update the Instructions for Use (IFU) for existing, already cleared devices to comply with new European regulations and for general readability improvements. Therefore, there is no study described in this document that proves a device meets acceptance criteria related to clinical performance or effectiveness, as this is solely a labeling update submission.

The document explicitly states: "There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices..." and "These modifications have no impact on the substantially equivalence between the subject devices and the predicate devices in terms of indications and design for the following technological characteristics: • Indications • Labelling (labels) • Design • Raw materials • Packaging • Biocompatibility • Stability • Sterilization".

However, the document does mention some performance data for trocar compatibility as part of continuous improvement initiatives related to the updated IFUs. This is a very specific type of bench test, not a clinical study on reader performance or standalone algorithm performance.

Here's a breakdown of what information can be extracted or inferred from the provided text, and what cannot based on the nature of this particular 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed performance results for the trocar compatibility test. It only states that the devices met the criteria.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified for the trocar compatibility bench test.
• Data Provenance: The document does not specify the country of origin for the bench test data. It is an in vitro (bench) test, not data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The "ground truth" here pertains to the physical performance of the mesh with a trocar, which is evaluated through engineering/bench testing, not expert interpretation of clinical data.

4. Adjudication method for the test set

• Not applicable. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This submission is for surgical mesh, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No standalone algorithm performance study was done. This submission is for surgical mesh, not an AI-powered device.

7. The type of ground truth used

• For the mentioned performance data (trocar compatibility): The ground truth would be the objective measurements and engineering standards applied during the in vitro bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm submission requiring training data.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/algorithm submission requiring training data.

Ask a specific question about this device

PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.

PARIETEX™ PROGRIP™ Mesh will be available in 2 shapes:
Pre-cut, elliptic slit mesh with a self-gripping overlapping flap. Right or left side.
Rectangular simple mesh.
These meshes and the overlapping flaps of the pre-cut versions are made from knitted monofilament polyester with monofilament polylactic acid (PLA) resorbable pins on one side. The PLA pins facilitate placing, positioning and fixation of the overlapping flap and the meshes to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps in orientation.

The acceptance criteria and study proving device performance are not explicitly detailed within the provided text beyond a general statement that "Bench and animal testing has been conducted to evaluate the performance characteristics of PARIETEX™ PROGRIP™ Mesh. Results of mechanical property testing show that PARIETEX™ PROGRIP™ has similar performance characteristics to the predicate PARIETEX™ Mesh."

Therefore, I cannot provide a detailed table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, or specifics on ground truth establishment for a training set.

Based on the provided information, I can deduce the following:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Test set sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Bench and animal testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study involved bench and animal testing, not human expert evaluations for establishing ground truth in the context of diagnostic performance.

4. Adjudication method for the test set

Not applicable. The study involved bench and animal testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a medical mesh device, not an AI-powered diagnostic tool, so an MRMC study is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical mesh device, not an algorithm.

7. The type of ground truth used

For mechanical properties, the "ground truth" would be established by predefined engineering specifications or comparison against the predicate device's measured performance. For material biocompatibility, the "ground truth" is adherence to ISO 10993-1 and/or USP standards.

8. The sample size for the training set

Not applicable. This is a medical mesh device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device does not use a training set in the context of machine learning.

Ask a specific question about this device

The PCO-OS and PCO-OB meshes are used for the reinforcement of tissues during surgical repair. They are indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

The PARIETEX COMPOSITE PCO-OS and PCO-OB Meshes are surgical meshes used during open (laparotomy) procedures or during laparoscopic procedures. The meshes are made from polyethylene terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the meshes but serves to separate the coated side of the meshes from underlying tissues to minimize tissue attachment and ingrowth. The PCO-OB and PCO-OS Meshes are offered in several sizes and shapes to accommodate the type and approach of the surgical procedure. The Sofradim PCO-OS and PCO-OB Meshes are identical to the predicate PARIETEX COMPOSITE (PCO) meshes (K002699 and K040998) with the exception of the addition of a bi-dimensional textile flap to the current threedimensional reinforcement on the PCO Mesh. This flap is manufactured and sewn to the three-dimensional textile with the same polyester yarn as described in the predicate PCO meshes as well as other PARIETEX meshes (K982532 and K003990). The bidimensional flap has been added to the parent PCO Meshes to ease placement and fixation of the mesh during open surgery.

The provided text is a 510(k) summary for a medical device (surgical mesh). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or a study specifically designed to prove that the device meets such criteria.

The "PERFORMANCE TESTING" section only states: "A study was conducted and demonstrated that the sewing of the additional flap does not adversely affect the safety or effectiveness of the device." This is a very general statement and lacks the specific details required for the requested table and study information.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are mentioned.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth and their qualifications: Not mentioned (as no specific performance study with ground truth is detailed).
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone performance study: Not mentioned.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily by highlighting that the new device (PCO-OS and PCO-OB Meshes) is identical to the predicate PCO meshes (K002699 and K040998) with only the addition of a bi-dimensional textile flap. The "performance testing" mentioned is merely to confirm that this modification does not adversely affect safety or effectiveness, not to establish specific performance metrics against pre-defined acceptance criteria for the entire device.

Ask a specific question about this device